Process-Based Therapy in an Outpatient Setting

NCT05105568 | Terminated

• 1 other identifier: 6214
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to examine the effects of process-based therapy on 6 adult patients presenting for treatment at a university community outpatient clinic using a nonconcurrent multiple baseline design.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Individual network structure

  Network models will be created using intensive longitudinal data collected four times daily. Variables to be measured will depend on the participant's presenting concern. For example, if Participant A reports struggling with avoiding work meetings related to fears about how they will be perceived by their supervisor and co-workers, then we might track percentage of work meetings attended (behavioral goal) and fear of social evaluation (source of distress). Where possible, these items will be assessed using a visual analog scale ranging from 0 to 100 to ensure an adequate range of responding. Because items will be personalized to the participant's presenting concern, we will not be using a standardized scale or questionnaire. Rather, we will be developing idiographic items specific to the participant's presentation and assess variables relevant to the individual.

  Up to 7 months

Secondary Outcomes (1)

• Process-Based Assessment Tool

  Up to 7 months

Study Arms (1)

Process-based therapy

EXPERIMENTAL

Behavioral: Process-based therapy

Interventions

Process-based therapy BEHAVIORAL

Process-based therapy (PBT) is a meta-theoretical model of evidence-based therapies that organizes adaptive and maladaptive processes of change using complex and dynamic networks based on an evolution science framework. Depending on the participant's presentation, PBT would be shaped by different evidence-based techniques. Examples of evidence-based procedures include: behavioral activation, exposures, mindfulness, self-compassion, values exploration, and contingency management.

Process-based therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to provide written informed consent
• Ability to sufficiently communicate in English as assessed through phone screening and the ability to answer study questionnaires
• At least 18 years old
• Seeking psychological treatment at CARD (participants do not need to meet criteria for a specific Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis)
• Willingness to abstain from other psychotherapies for duration of study (up to 1-month follow-up; this is so we can be more confident that changes observed during the study are attributable to the study intervention rather than an external intervention; clinically, it is also typically counterproductive for a patient to see multiple therapists at the same time)
• Working smartphone with internet connection
• Stable on current psychotropic medications (or off medication for 2 weeks)
• If participating remotely, access to private room where they will not be disturbed during study sessions

You may not qualify if:

• Suicidality (ideation, intent, or specific plan) significant enough to require higher level of care than outpatient, as determined by CARD phone screening (patients on the CARD waitlist who comprise our recruitment pool are prescreened), the Mini International Neuropsychiatric Interview (MINI), or otherwise determined by the Investigator
• Currently receiving another psychological treatment
• Active psychosis, mania, or significant personality dysfunction as assessed through CARD phone screening (patients on the CARD waitlist who comprise our recruitment pool are prescreened), the MINI, or otherwise determined by the Investigator
• Serious neurological impairment as assessed through phone screening items or otherwise determined by the Investigator
• Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, interfere with study compliance, or confound study results

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Center for Anxiety and Related Disorders (CARD)

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Ciarrochi, J., Hayes, S. C., & Hofmann, S. G. (2021). Assessing processes of change in psychological interventions: The Process-Based Assessment Tool (PBAT). Manuscript in preparation. Institute for Positive Psychology and Education, Australian Catholic University.

  BACKGROUND

• Hofmann, S. G., Hayes, S. C., & Lorscheid, D. N. (2021). Learning process-based therapy: A skills training manual for targeting the core processes of psychological change in clinical practice. New Harbinger.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nonconcurrent multiple baseline design with three dyads.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 3, 2021
• Study Start: November 16, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)